Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
RMC-6236-001 (primary)
NCI-2022-05170
Summary
Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant
advanced solid tumors.
Objectives
This is a Phase 1/2, multicenter open-label study to evaluate the safety, tolerability,
pharmacokinetics (PK), and clinical activity of escalating doses of RMC-6236 in adult
patients with advanced solid tumors harboring specific RAS mutations, and to determine
the maximum tolerated dose (MTD) and/or recommended phase 2 dose [RP2D] within
investigated patient population groups. RMC-6236 is a potent, orally bioavailable
RAS-MULTI(ON) inhibitor, selective for the active RAS(ON) form of both wild type and
mutant variants of the canonical RAS isoforms (HRAS, NRAS, and KRAS).
Eligibility
- Histologically confirmed advanced solid tumor with specific KRAS G12 mutations (dose escalation) or RAS mutations (dose optimization/expansion) identified through deoxyribonucleic acid (DNA) sequencing. PDAC with wild-type RAS (expansion).
- Treatment naive or have received prior standard therapy appropriate for tumor type and stage
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
Treatment Sites in Georgia
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